Versions Compared

Old Version 5

changes.mady.by.user Jon Neville

Saved on

compared with

New Version Current

changes.mady.by.user Jon Neville

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
  1.  IN is a special-purpose domain for listing the non-tobacco ingredients (only) for a tobacco product. Tobacco ingredients (e.g., such as individual tobacco varieties) would not be represented in this domain (see Section 2.8.8.4, SDTM Tobacco Ingredients, for IT domain specification and assumptions for more information on handling tobacco ingredients).
  2. IN is one 1 of two 2 domains (along with IT) that serve as the origin of the consistent identifier variable IGDCMPID (Ingredient or Component Identifier).
    1. IGDCMPID must represent a non-tobacco ingredient that is unique with regard to the attributes listed in assumption 3 below. If two 2 or more sources of the same non-tobacco ingredient differ on any of these attributes, they must each be assigned a different value for INGCMPID IGDCMPID (e.g., 1,3-Butanediol A, 1,3-Butanediol B).
    2. IGDCMPID is also used with the same values in the Ingredient Quantities by Component (IQ) domain, where the ingredients identified by those values are quantified by component (See . When quantifying ingredients in IQ, every ingredient (every value of IGDCMPID in IN) must be accounted for in IQ (see Section 2.8.8.6 for IQ domain specification and assumptions for more information).
  3. Additionally, IN contains variables for representing the following attributes:
    1. Manufacturer's name and registration number (INMANUF)
    2. Manufacturer's unique identifying item number for the ingredient or component (INMANUIN)
    3. Tobacco Product Master File product master file number (TPMF) number
    4. IUPAC name and CAS Registry number. At least one of these variables should be populated if the data are available. (IUPACNAM), CAS registry number (CASNO), and FDA Unique Ingredient Identifier (UNII), with the following requirements for inclusion in the IN dataset:
      1. IUPACNAM is an expected variable, and should be populated with the preferred IUPAC name for all ingredients for which
      2. If an IUPAC name is not available, CASNO should be populated.
      3. The preferred IUPAC name should be used, if available
      4. If both are available, both should be populated.
    5. Ingredient grade and purity
     At least one of the variables IUPAC or CASNO must be populated, if available.
      1. IUPAC nomenclature is available at https://iupac.org/.
      2. At least 1 of the 2 permissible variables CASNO or UNII should also be provided if available. CAS numbers are available at https://www.cas.org/. UNII identifiers are available https://precision.fda.gov/uniisearch. 
    2. The complexity of the ingredient (INIGDPLX), to differentiate between single ingredients and complex ingredients, and a separate indicator (INCIGIND) as to whether a complex ingredient was made to the applicant's specifications
    3. Ingredient grade (INGRADE) and purity (INPURITY). According to the PMTA rule, at least 1 of these 2 attributes must be included. If the data are proprietary and only available via the TPMF, then TPMF should be populated. 
    4. If an IUPAC name is not available, CASNO should be populated.
    5. The preferred IUPAC name should be used, if available
    6. If both are available, both should be populated.